S0350 Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Peripheral T-Cell Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00109928
Recruitment Status : Completed
First Posted : May 4, 2005
Results First Posted : August 29, 2014
Last Update Posted : October 1, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Lymphoma
Interventions: Drug: cisplatin
Drug: etoposide
Drug: gemcitabine
Drug: methylprednisolone

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
PEGS Patients received IV cisplatin 25 mg/m2 days 1–4, etoposide 40 mg/m2 days 1–4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1–4 of a 21 day cycle for 6 cycles.

Participant Flow:   Overall Study
Eligible   33 
Eligible and Began Protocol Therapy   33 
Adverse Event                2 
Progression                6 
Death                2 
not protocol specified                2 
not eligible                1 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Peripheral T-cell lymphomas (PTCLs) with stage II bulky, III or IV with extra-nodal, nodal and transformed cutaneous presentations were eligible.

Reporting Groups
PEGS Patients received IV cisplatin 25 mg/m2 days 1–4, etoposide 40 mg/m2 days 1–4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1–4 of a 21 day cycle for 6 cycles.

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Median (Full Range)
 (20 to 92) 
[Units: Participants]
Female   11 
Male   22 
Ethnicity (NIH/OMB) 
[Units: Participants]
Hispanic or Latino   2 
Not Hispanic or Latino   31 
Unknown or Not Reported   0 
Race (NIH/OMB) 
[Units: Participants]
American Indian or Alaska Native   0 
Asian   1 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   4 
White   28 
More than one race   0 
Unknown or Not Reported   0 

  Outcome Measures

1.  Primary:   2-year Overall Survival Rate   [ Time Frame: 0-2 years ]

2.  Secondary:   2-year Progression-free Survival Rate   [ Time Frame: 0-2 years ]

3.  Secondary:   Response Rate   [ Time Frame: up to 3 years or time of disease progression ]

4.  Secondary:   Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug   [ Time Frame: up to 18 weeks of protocol treatment ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Study Statistician
Organization: SWOG Statistical Center
phone: 206-667-4623

Publications of Results:

Responsible Party: Southwest Oncology Group Identifier: NCT00109928     History of Changes
Other Study ID Numbers: CDR0000425643
S0350 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: May 3, 2005
First Posted: May 4, 2005
Results First Submitted: June 11, 2014
Results First Posted: August 29, 2014
Last Update Posted: October 1, 2014